This study will evaluate the steady-state pharmacokinetics (PK) and confirm the dose of ritonavir (RTV)-boosted elvitegravir (EVG/r). This study will also evaluate the safety, tolerability, and antiviral activity of elvitegravir (EVG) administered with a background regimen containing a ritonavir-boosted protease inhibitor (PI/r) in HIV-1 infected, antiretroviral (ARV) treatment-experienced pediatric participants.

The study consists of 2 parts: Part A and Part B. Part A will enroll participants with suppressed viremia (HIV-1 RNA < 50 copies/mL) or failing a current ARV regimen (HIV-1 RNA > 1,000 copies/mL) to evaluate the steady state PK and confirm the dose of EVG. Part B will enroll participants who are failing a current ARV regimen (HIV-1 RNA > 1,000 copies/mL) to evaluate the safety, tolerability, and antiviral activity of EVG.

Part A: No participants will be enrolled in Part A, as PK data is currently available for this age group.

Part B: Participants will receive EVG plus a background regimen that includes a PI/r for up to 48 weeks.

Drug: EVG

Elvitegravir (EVG) tablets or tablets for oral suspension (if unable to swallow) will be administered orally

Other Name: Vitekta®

Drug: Background regimen

Background regimen may consist of the following RTV-boosted PIs (PI/r): lopinavir/r (Kaletra), atazanavir/r, darunavir/r, tipranavir/r, or fosamprenavir/r. For participants < 2 months old, only lopinavir/r is allowed. Use of additional antiretrovirals in background therapy may be allowed.

Experimental: Cohort 2 (6 to < 12 years of age)

Part A: Participants will receive EVG plus a background regimen that includes a PI/r for 10 days. Participants with HIV-1 RNA > 1,000 copies/mL who complete Part A may then choose to continue in Part B.

Part B: Following safety and PK assessment, participants will receive EVG plus a background regimen that includes a PI/r for up to 48 weeks.

Drug: EVG

Elvitegravir (EVG) tablets or tablets for oral suspension (if unable to swallow) will be administered orally

Other Name: Vitekta®

Drug: Background regimen

Background regimen may consist of the following RTV-boosted PIs (PI/r): lopinavir/r (Kaletra), atazanavir/r, darunavir/r, tipranavir/r, or fosamprenavir/r. For participants < 2 months old, only lopinavir/r is allowed. Use of additional antiretrovirals in background therapy may be allowed.

Experimental: Cohort 3 (2 to < 6 years of age)

Part A: Participants will receive EVG plus a background regimen that includes a PI/r for 10 days. Participants with HIV-1 RNA > 1,000 copies/mL who complete Part A may then choose to continue in Part B.

Part B: Following safety and PK assessment, participants will receive EVG plus a background regimen that includes a PI/r for up to 48 weeks.

Drug: EVG

Elvitegravir (EVG) tablets or tablets for oral suspension (if unable to swallow) will be administered orally

Other Name: Vitekta®

Drug: Background regimen

Background regimen may consist of the following RTV-boosted PIs (PI/r): lopinavir/r (Kaletra), atazanavir/r, darunavir/r, tipranavir/r, or fosamprenavir/r. For participants < 2 months old, only lopinavir/r is allowed. Use of additional antiretrovirals in background therapy may be allowed.

Experimental: Cohort 4 (4 weeks to < 2 years of age)

Part A: Participants 6 months to < 2 years of age will be enrolled and upon review of safety and PK data, enrollment will be open for participants 4 weeks to < 6 months of age. Participants with HIV-1 RNA > 1,000 copies/mL who complete Part A may then choose to continue in Part B.

Part B: Following safety and PK assessment, participants will receive EVG plus a background regimen that includes a PI/r for up to 48 weeks.

Drug: EVG

Elvitegravir (EVG) tablets or tablets for oral suspension (if unable to swallow) will be administered orally

Other Name: Vitekta®

Drug: Background regimen

Background regimen may consist of the following RTV-boosted PIs (PI/r): lopinavir/r (Kaletra), atazanavir/r, darunavir/r, tipranavir/r, or fosamprenavir/r. For participants < 2 months old, only lopinavir/r is allowed. Use of additional antiretrovirals in background therapy may be allowed.

Eligibility

Ages Eligible for Study:

up to 17 Years (Child)

Genders Eligible for Study:

Both

Accepts Healthy Volunteers:

No

Criteria

Key Inclusion Criteria:

Individuals must meet all of the following inclusion criteria to be eligible for participation in this study. Individuals with screening results that do not meet eligibility criteria will not be allowed to rescreen.

HIV-1 infected male and female individuals 4 weeks (gestational age of at least 44 weeks) to less than 18 years of age at Baseline.

Individuals are able to provide written assent if they have the ability to read and write.

Parent or legal guardian able to provide written informed consent prior to any screening evaluations and willing to comply with study requirements.

Body weight at screening greater than 5kg, 10.6kg, or 15kg dependent upon age cohort

Adequate renal function

Adequate hematologic function

Hepatic transaminases (AST and ALT) less than or equal to 5 x upper limit of normal (ULN)

Total bilirubin less than or equal to 1.5 mg/dL, or normal direct bilirubin

Negative serum pregnancy test

Individuals with evidence of suppressed viremia

Individuals failing a current antiretroviral regimen at study entry

Male and female individuals of childbearing potential must agree to utilize highly effective contraception methods while on study treatment or agree to abstain from heterosexual intercourse of reproductive potential throughout the study period and for 30 days following the last dose of study drug

Must be willing and able to comply with all study requirements.

Key Exclusion Criteria:

Participants who meet any of the following exclusion criteria are not to be enrolled in this study.

Individuals with CD4+ cell counts at Screening of less than 50, 75, or 200 cells/mm3 dependent on age cohort

An AIDS defining condition with onset within 30 days prior to screening

Life expectancy of less than 1 year

For Individuals with HIV-1 RNA greater than 1,000 copies/mL at screening, prior treatment of any duration with an integrase strand transfer inhibitor.

An ongoing serious infection requiring systemic antibiotic therapy at the time of screening.

Evidence of active pulmonary or extra-pulmonary tuberculosis disease

Anticipated requirement for rifamycin treatment while participating in the study.

Have any serious or active medical or psychiatric illness which, in the opinion of the Investigator, would interfere with Individual's treatment, assessment, or compliance with the protocol.

Individuals experiencing decompensated cirrhosis

A history of or ongoing malignancy other than cutaneous Kaposi's sarcoma (KS), basal cell carcinoma, or resected, non-invasive cutaneous squamous carcinoma.

Pregnant or lactating females.

Current alcohol or substance abuse judged by the Investigator to potentially interfere with individual's compliance.

Have history of significant drug sensitivity or drug allergy.

Known hypersensitivity to the study drug, the metabolites, or formulation excipients.

Have previously participated in an investigational trial involving administration of any investigational agent within 30 days prior to the study dosing.

Participation in any other clinical trial without prior approval from sponsor is prohibited while participating in this trial.

Individuals receiving ongoing therapy with any medication that is not to be taken with EVG or a component of the BR, including drugs not to be used with ritonavir

NOTE: Other protocol defined Inclusion/ Exclusion criteria may apply.

Contacts and Locations

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study.
To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below.
For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01923311